2014 Test Procedure Draft for 170.314(b)(2 -

Test Procedure for §170.314.b.2 Transitions of care- create and transmit summary care records For Public Comment October 17, 2012

1

Test Procedure for §170.314 (b)(2) Transitions of care – create and transmit summary care records

This document describes the test procedure for evaluating conformance of complete EHRs or EHR

modules to the certification criteria defined in 45 CFR Part 170 Subpart C of the Health Information

Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health

Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health

Information Technology, Final Rule. The document1 is organized by test procedure and derived test

requirements with traceability to the normative certification criteria as described in the Overview document

located at [available when final]. The test procedures may be updated to reflect on-going feedback

received during the certification activities.

The HHS/Office of the National Coordinator for Health Information Technology (ONC) has defined the

standards, implementation guides and certification criteria used in this test procedure. Applicability and

interpretation of the standards, implementation guides and certification criteria to EHR technology is

determined by ONC. Testing of EHR technology in the Permanent Certification Program, henceforth

referred to as the ONC HIT Certification Program2, is carried out by National Voluntary Laboratory

Accreditation Program-Accredited Testing Laboratories (ATLs) as set forth in the final rule establishing

the Permanent Certification Program (Establishment of the Permanent Certification Program for Health

Information Technology, 45 CFR Part 170; February 7, 2011.)

Questions or concerns regarding the ONC HIT Certification Program should be directed to ONC at

[email protected].

CERTIFICATION CRITERIA

This Certification Criterion is from the Health Information Technology: Standards, Implementation

Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions

to the Permanent Certification Program for Health Information Technology, Final Rule issued by the

Department of Health and Human Services (HHS) on September 4, 2012.

§170.314(b)(2) Transitions of care - create and transmit summary care records

(i) Create. Enable a user to electronically create a transition of care/referral summary formatted (2)

Transitions of care – create and transmit transition of care/referral summaries.

(i) Create. Enable a user to electronically create a transition of care/referral summary formatted

according to the standard adopted at § 170.205(a)(3) that includes, at a minimum, the Common MU

Data Set and the following data expressed, where applicable, according to the specified standard(s):

1 Disclaimer: Certain commercial products may be identified in this document. Such identification does not imply

recommendation or endorsement by ONC. 2 Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic

Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology, Final Rule

mailto:[email protected]


2

(A) Encounter diagnoses. The standard specified in § 170.207(i) or, at a minimum, the version of

the standard specified § 170.207(a)(3);

(B) Immunizations. The standard specified in § 170.207(e)(2);

(C) Cognitive status;

(D) Functional status; and

(E) Ambulatory setting only. The reason for referral; and referring or transitioning provider’s name

and office contact information.

(F) Inpatient setting only. Discharge instructions.

(ii) Transmit. Enable a user to electronically transmit the transition of care/referral summary created in

paragraph (b)(2)(i) of this section in accordance with:

(A) The standard specified in § 170.202(a).

(B) Optional. The standards specified in § 170.202(a) and (b).

(C) Optional. The standards specified in § 170.202(b) and (c).

Per Section III.A of the preamble of the Health Information Technology: Standards, Implementation


to the Permanent Certification Program for Health Information Technology, Final Rule, the 2014 Edition of

this Certification Criterion is classified as revised from the 2011 Edition. This Certification Criterion meets

at least one of the three factors of revised certification criteria: (1) the certification criterion includes

changes to capabilities that were specified in the previously adopted certification criterion, (2) the

certification criterion has a new mandatory capability that was not included in the previously adopted

certification criterion, or (3) the certification criterion was previously adopted as “optional” for a particular

setting and is subsequently adopted as “mandatory” for that setting.



to the Permanent Certification Program for Health Information Technology, Final Rule where the

transitions of care – create and transmit summary care records certification criterion is discussed:

“… based on stakeholder feedback received after the publication of the S&CC July 2010 final

rule, we stated our belief that the criterion should be split into two separate certification criteria

based on the capabilities required. We explained that this approach would provide developers

greater flexibility for certification…”

“…we have decided to finalize our proposal to allow for the use of ICD-10-CM to represent

encounter diagnoses in addition to permitting SNOMED- CT…”

“…In instances where the EP, EH, or CAH’s CEHRT receives data from an outside source, we

acknowledge that requiring the CEHRT to translate the data into an adopted standard vocabulary

could alter its intended meaning … the responsibility of the sending EP or EH/CAH is to send

information with standard terms, and in the case when such standard terms are not used, it

should not be the responsibility of the receiving EP or EH to translate local or proprietary codes

into standard codes …”

“…for the purposes of certification, and demonstrating compliance with this certification criterion,

EHR technology will need to be tested and certified as being able to apply all of the adopted


3

standard vocabularies to data required to be included in a Consolidated CDA formatted transition

of care/referral summary …”

“…Further, we expect that the National Coordinator will approve a test procedure for the

transitions of care certification criteria that rigorously assesses EHR technology’s ability to

transmit and receive electronic health information according to the adopted transport, content

exchange, and vocabulary standards. We anticipate that this test procedure will be specified to

ascertain the EHR technology’s ability to engage in standards-based exchange with any other

EHR technology that has also implemented the standards we have adopted …”

“…We acknowledged that care plan, additional care team members, referring or transitioning

provider’s name and contact information as well as certain hospital discharge information are not

explicitly required to be captured by separate certification criteria, unlike most other data included

in the summary care record. We noted that the ability to capture these data elements is both

implicit and necessary to satisfy this certification criterion …”

CHANGES FROM 2011 TO 2014 EDITION



to the Permanent Certification Program for Health Information Technology, Final Rule where the

transitions of care – create and transmit summary care records certification criterion is discussed:

“…we proposed to adopt the Consolidated CDA for this certification criterion because its

template structure can accommodate the formatting of a summary care record that includes all of

the data elements that CMS proposed be available for inclusion in a summary care record.”

“We proposed that EHR technology would need to be capable of transmitting a summary care

record according to both of the Direct Project’s specifications for secure transport. We also

proposed to adopt as an optional standard at § 170.202(a)(3) the SOAP-Based Secure Transport

RTM version 1.03 which was developed under the nationwide health information network

Exchange Initiative and to which we stated EHR technology should be able to be certified.”

“We have adopted, as proposed, that the Applicability Statement for Secure Health Transport

specification be a required condition of certification as part of this certification criterion. We have

removed the XDR and XDM for Direct Messaging specification as also being required in lieu of a

broader range of options for certification.”

“Additionally…, all EHR technology used by EPs, EHs, and CAHs and that meets the CEHRT

definition will, at a minimum, be capable of SMTP-based exchange.”

“…we have adopted the updated version of this specification that was established by the

stakeholder community during this final rule’s drafting.”

“…we have adopted two optional certification approaches for transport standards…

o The first option would permit EHR technology to be certified as being in compliance with

our original proposal: certification to both the Applicability Statement for Secure Health

Transport specification and the XDR and XDM for Direct Messaging specification.

3 http://modularspecs.siframework.org/NwHIN+SOAP+Based+Secure+Transport+Artifacts

http://modularspecs.siframework.org/NwHIN+SOAP+Based+Secure+Transport+Artifacts


4

o The second option would permit EHR technology to be certified to: the Simple Object

Access Protocol (SOAP)-Based Secure Transport Requirements Traceability Matrix

(RTM) version 1.0 standard and the XDR and XDM for Direct Messaging specification.”

“We have included the XDR and XDM for Direct Messaging specification as a required

specification for both of these options.”

INFORMATIVE TEST DESCRIPTION

This section provides an informative description of how the test procedure is organized and conducted. It

is not intended to provide normative statements of the certification requirements.

ONC provides the test data for this test procedure. This test procedure is organized into two required

sections (and two optional sections):

Create – evaluates the capability to create a transition of care/referral summary from the EHR in C-

CDA format. Included in the test procedure is an evaluation of the capability to use specified

vocabularies as defined by the referenced standards.

o For both ambulatory and inpatient settings: the Common MU Data Set data with named

standards as appropriate (in their English representation if they associate with a

vocabulary/code set):

1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity

6) Preferred language

7) Smoking status

8) Problems

9) Medications

10) Medication Allergies

11) Laboratory test(s)

12) Laboratory value(s)/result(s)

13) Vital signs – height, weight, blood pressure, BMI

14) Care plan field(s), including goals and instructions

15) Procedures

16) Care team member(s)

o For ambulatory settings only: encounter diagnoses, immunizations, cognitive status,

functional status, reason for referral, referring provider’s name and contact information

o For inpatient settings only: encounter diagnoses, immunizations, cognitive status, functional

status, and discharge instructions

o The Vendor creates an existing patient record in the EHR technology with health information

based on the ONC-provided test data


5

o Tester, logs into the online application as a provider and creates a referral summary/transition

of care

Transmit - Evaluates the capability of EHR technology to allow a provider to electronically transmit the

health information created in the “Create” section of the test procedure another provider or next

setting of care:

o The Tester logs in to the EHR's online technology as the provider who created the

information in the “Create” step

o The Tester verifies that the EHR can discover certificates from other parties in either DNS

CERT records or LDAP servers

o Using the Vendor-identified function(s), the Tester verifies that the EHR is able to create and

store a listing of Direct recipient address(es)

o Using the Vendor-identified function(s), the Tester causes the health information in C-CDA

format to be transmitted to a third party using the Direct transport standard, based on ONC

supplied test information

o The Tester verifies successful transmission and receipt of the health information, and that the

health information can be successfully decrypted

o The Tester verifies that the information transmitted is in conformance with the C-CDA

Using the Vendor-identified EHR function(s), the Tester imports the health

information into the NIST Transport Test Tool

Using the Validation Report produced by the NIST Transport Test Tool, the Tester

verifies that the Implementation Guide conformance requirements tested are met,

and that the named standard vocabularies have been used where applicable for data

in the Common MU Data Set

o Using the provided test data, the Tester verifies that the data rendered in the transmitted C-

CDA are complete and accurate, and that the data in the Common MU Data Set are shown in

their English representation if they associate with a vocabulary/code set

o Optional: Using the Vendor-identified function(s), the Tester causes the health information in

human readable format or C-CDA format to be transmitted to a third party using Direct and

the Cross-Enterprise Document Reliable Interchange (XDR) and Cross-Enterprise Document

Media Interchange (XDM) for Direct Messaging Specification, based on ONC supplied test

information

Optional: Using the Vendor-identified function(s), the Tester causes the health information in

human readable format or C-CDA format to be transmitted to a third party using the SOAP-

Based Secure Transport RTM version 1.0 and XDR, based on ONC supplied test information


6

REFERENCED STANDARDS

§170.202 Transport standards. Regulatory Referenced Standard

The Secretary adopts the following transport standards:

(a) Standard. ONC Applicability Statement for Secure Health Transport (incorporated by reference in § 170.299).

(b) Standard. ONC XDR and XDM for Direct Messaging Specification (incorporated by reference in § 170.299).

(c) Standard. ONC Transport and Security Specification (incorporated by reference in § 170.299).

§170.205 Content exchange standards and implementation specifications for exchanging electronic

health information. Regulatory Referenced Standard

The Secretary adopts the following content exchange standards and associated implementation specifications:

(a)(3) Standard. HL7 Implementation Guide for CDA®

Release 2: IHE Health Story Consolidation, (incorporated by reference in § 170.299). The use of the “unstructured document” document-level template is prohibited.

§170.207 Vocabulary standards for representing electronic health information.

Regulatory Referenced Standard

The Secretary adopts the following code sets, terminology, and nomenclature as the vocabulary standards for the purpose of representing electronic health information:

(a)(3) Standard. IHTSDO SNOMED CT® International

Release July 2012 (incorporated by reference in § 170.299) and US Extension to SNOMED CT

®

March 2012 Release (incorporated by reference in § 170.299).


7



(b)(2) Standard. The code set specified at 45 CFR 162.1002(a)(5).

45 CFR 162.1002 Medical data code sets The Secretary adopts the following code set maintaining organization’s code sets as the standard medical data code sets:

(a) International Classification of Diseases, 9th Edition, Clinical Modification, (ICD-9- CM), Volumes 1 and 2 (including The Official ICD-9-CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following conditions:

(5) The combination of Health Care Financing Administration Common Procedure Coding System (HCPCS), as maintained and distributed by HHS, and Current Procedural Terminology, Fourth Edition (CPT–4), as maintained and distributed by the American Medical Association, for physician services and other health care services. These services include, but are not limited to, the following:

(b)(3) Standard. The code set specified at 45 CFR 162.1002(a)(4).


(a) International Classification of Diseases, 9th Edition, Clinical Modification, (ICD-9- CM), Volumes 1 and 2 (including The Official ICD-9-CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following conditions:

(4) Code on Dental Procedures and Nomenclature, as maintained and distributed by the American Dental Association, for dental services.

(4) Standard. The code set specified at 45 CFR 162.1002(c)(3) for the indicated procedures or other actions taken.


(c)(3) International Classification of Diseases, 10th Revision, Procedure Coding System (ICD–10–PCS) (including The Official ICD–10–PCS Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients reported by hospitals:

(i) Prevention. (ii) Diagnosis. (iii) Treatment. (iv) Management.


8



(c) Laboratory tests. (2) Standard. Logical Observation Identifiers Names and Codes (LOINC

®) Database version 2.40, a universal

code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (incorporated by reference in § 170.299).

(d) Medications. (2) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, August 6, 2012 Release (incorporated by reference in § 170.299).

(e) Immunizations. (2) Standard. HL7 Standard Code Set CVX -- Vaccines Administered, updates through July 11, 2012 (incorporated by reference in § 170.299).

(f) Race and Ethnicity. Standard. The Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997 (see “Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity,” available at http://www.whitehouse.gov/omb/fedreg_1997standards).

(g) Preferred language. Standard. As specified by the Library of Congress, ISO 639-2 alpha-3 codes limited to those that also have a corresponding alpha-2 code in ISO 639-1. (incorporated by reference in § 170.299).

(h) Smoking status. Standard. Smoking status must be coded in one of the following SNOMED CT

® codes:

(1) Current every day smoker. 449868002 (2) Current some day smoker. 428041000124106 (3) Former smoker. 8517006 (4) Never smoker. 266919005 (5) Smoker, current status unknown. 77176002 (6) Unknown if ever smoked. 266927001 (7) Heavy tobacco smoker. 428071000124103

(8) Light tobacco smoker. 428061000124105

http://www.whitehouse.gov/omb/fedreg_1997standards


9



(i) Encounter diagnoses. Standard. The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions.

45 CFR 162.1002 Medical data code sets. The Secretary adopts the following maintaining organization’s code sets as the standard medical data code sets: (c)(2) International Classification of

Diseases, 10th Revision, Clinical Modification (ICD–10–CM) (including The Official ICD–10–CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following conditions: (i) Diseases. (ii) Injuries. (iii) Impairments. (iv) Other health problems and their

manifestations. (v) Causes of injury, disease,

impairment, or other health problems.

NORMATIVE TEST PROCEDURES

Derived Test Requirements

DTR170.314.b.2–1: Create Referral Summary/Transition of Care

DTR170.314.b.2–2: Transmit Health Information to a Third Party Using Direct

DTR170.314.b.2–3: Transmit Health Information to a Third Party Using Direct and XDM Validation

(Optional)

DTR170.314.b.2–4: Transmit Health Information to a Third Party Using SOAP Protocols (Optional)

DTR170.314.b.2–1: Create Referral Summary/Transition of Care

Required Vendor Information

VE170.314.b.2 – 1.01: Using ONC-supplied test data, the Vendor shall create a test patient with an

existing record in the EHR to be used for this test as indicated in TD170.314.b.2 –

Ambulatory (ambulatory only) or TD170.314.b.2 – Inpatient (inpatient only)

VE170.314.b.2 – 1.02: Vendor shall identify a provider with authorized access to the patient’s record

VE170.314.b.2 – 1.03: Vendor shall identify the EHR function(s) that are available for a provider to view

health information including the named data elements as well as the Common MU

Data Set with associated vocabulary standards and create a referral

summary/transition of care document

Required Test Procedure

TE170.314.b.2 – 1.01: Using the Vendor-identified EHR function(s), the Tester shall access the ONC-

supplied test patient’s record as the provider


10

TE170.314.b.2 – 1.02: Using the Vendor-identified EHR function(s), the Tester shall view and create

patient information that includes:

Ambulatory Summary: Common MU Data Set and the following data

elements: encounter diagnoses, immunizations, cognitive status, functional

status, reason for referral, referring provider’s name and contact information

(Ambulatory EHR Only)

Inpatient Summary: Common MU Data Set and encounter diagnoses,

immunizations, cognitive status, functional status, and discharge instructions

(Inpatient EHR Only)

TE170.314.b.2 – 1.03: Using the Inspection Test Guide, the Tester shall verify that the summary

information is complete and accurate and in accordance with TD170.314.b.2 –

Ambulatory (ambulatory only) or TD170.314.b.2 – Inpatient (inpatient only)

TE170.314.b.2 – 1.04: Using the Inspection Test Guide, the Tester shall verify that the created referral

summary/transition of care information is complete and accurate

Inspection Test Guide

IN170.314.b.2 – 1.01: Using the ONC-provided test data, the Tester shall inspect the content of the C-

CDAs is complete and accurate


11

DTR170.314.b.2–2: Transmit Health Information to a Third Party Using Direct

Figure 1


VE170.314.b.2 – 2.01: The Vendor shall identify a Direct address and a registered domain for sending of

Direct messages for certificate discovery testing

VE170.314.b.2 – 2.02: The Vendor shall identify a non-Direct email address to be used for delivery of

results of certificate discovery testing

VE170.314.b.2 – 2.03: The Vendor shall identify a Contact Email address to be used for receipt of the

validation report generated by the Transport Testing Tool

VE170.314.b.2 – 2.04: The Vendor shall identify the Direct address for registering within the Transport

Testing Tool

VE170.314.b.2 – 2.05: The Vendor shall obtain the Transport Testing Tool’s Public Key and Trust Anchor

from the Transport Testing Tool and store it within EHR technology for encrypting

Direct message(s) to be sent to another setting of care or provider of care

Required Test Procedures

TE170.314.b.2 – 2.01: The Tester shall download the Direct Certificate Discovery Tool’s Trust Anchor

and import it into the EHR technology’s trust store


12

TE170.314.b.2 – 2.02: The Tester shall use the Direct (From) address provided in VE170.314.b.2-2.01 to

execute the test using the Direct Certificate Discovery Tool

TE170.314.b.2 – 2.03: The Tester shall use the non-Direct email address provided in VE170.314.b.2-2.02

for receipt and validation of results of certificate discovery testing

TE170.314.b.2 – 2.04: The Tester shall execute all test cases within the Direct Certificate Discovery Tool

TE170.314.b.2 – 2.05: Using the Inspection Test Guide, the Tester shall verify that the EHR technology is

able to correctly discover and use address-bound and domain-bound certificates

hosted in both DNS and LDAP

TE170.314.b.2 – 2.06: The Vendor shall provide the recipient with a valid Trust Anchor

TE170.314.b.2 – 2.07: The Tester cause the EHR to register the Direct (To) addresses specified in the

Transport Testing Tool to be available as a recipient for sending of Direct

messages within the EHR

TE170.314.b.2 – 2.08: The Tester shall cause the EHR to transmit Consolidated CDA document(s) using

ONC Applicability Statement for Secure Health Transport (Direct) standard to the

Direct (To) address(es) specified in the Transport Testing Tool. The Direct

message shall be encrypted using the recipient’s (Transport Testing Tool) Public

Key obtained in VE170.314.b.2 – 2.05 and signed using the sender’s (Vendor)

Private Key for the Referral Summary/Transition of Care document created in

VE170.314.b.2 – 1.02

TE170.314.b.2 – 2.09: Using the Inspection Test Guide, the Tester shall verify that the Referral

Summary/Transition of Care is transmitted according to the Consolidated CDA

standard tested and the named vocabulary standards, and is complete and

accurate


IN170.314.b.2 – 2.01: Using the Direct Certificate Discovery Tool, the Tester shall inspect the results

received via email to verify that all test cases were successful

IN170.314.b.2 – 2.02: The Tester shall verify the appropriate Direct (To) address(es) (provided within the

Transport Testing Tool) have been registered within the EHR technology and are

visible Direct addresses for transmitting of health information to the Transport

Testing Tool according to the ONC Applicability Statement for Secure Health

Transport (Direct) standard

IN170.314.b.2 – 2.03: Using the Transport Testing Tool, the Tester shall verify that the transmitted C-CDA

document has been transmitted and received successfully according to the ONC

Applicability Statement for Secure Health Transport (Direct) standard, including

successful decryption validation and trust anchor validation

IN170.314.b.2 – 2.04: Using the provided test data, and the Validation Report produced by the Transport

Testing Tool identified in the Conformance Test Tools section of this test

procedure, the Tester shall verify that

The C-CDA Implementation Guide conformance requirements tested are met

by the electronically generated (Ambulatory/Inpatient) Transition of

Care/Referral Summary


13

The standards for the named vocabularies for the Common MU Data Set,

Encounter diagnoses, and Immunizations are met by the electronically

generated Transition of Care/Referral Summary

IN170.314.b.2 – 2.05: The Tester shall identify the C-CDA .xml files within the transmitted documents

(This may involve parsing files and inspecting the header to identify the C-CDA

documents (vs. style sheet, human readable document, etc.))

IN170.314.b.2 – 2.06: Using the ONC-provided test data, the Tester shall verify that the content of the

transmitted C-CDA is complete and accurate and includes, at a minimum, the

following data elements (Ambulatory Only):

1) Encounter diagnoses

2) Immunizations

3) Cognitive status

4) Functional status

5) Reason for referral

6) Referring or transitioning provider’s name

7) Provider name

8) Provider office contact information

and the Common MU Data Set (in their English representation if they associate

with a vocabulary/code set)

1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity


7) Smoking status

8) Problems

9) Medications






15) Procedures




following data elements (Inpatient Only):


2) Immunizations

3) Cognitive status


5) Discharge instructions


14



1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity


7) Smoking status

8) Problems

9) Medications






15) Procedures


DTR170.314.b.2–3: Transmit Health Information Using Direct and XDM Validation (Optional)


VE170.314.b.2 – 3.01: As defined in DTR170.314.b.2 – 1 and DTR170.314.b.2 – 2 no additional

information is required


TE170.314.b.2 – 3.01: The Tester cause the EHR to register the Direct (To) addresses specified in the

Transport Testing Tool to be available for Direct messaging with XDM Validation

within the EHR

TE170.314.b.2 – 3.02: The Tester shall cause the EHR to transmit Consolidated CDA document(s) using

ONC Applicability Statement for Secure Health Transport (Direct) standard with

XDM Validation to the Direct (To) address(es) specified in the Transport Testing

Tool that are available within the EHR following TE170.b.2 – 4.01. The Direct

message shall be encrypted using the recipient’s (Transport Testing Tool) Public

Key obtained in VE170.314.b.2 – 2.05 and signed using the sender’s (Vendor)

Private Key for the Referral Summary/Transition of Care document created in

VE170.314.b.2 – 1.02




accurate


15


IN170.314.b.2 – 3.01: The Tester shall verify the appropriate Direct (To) address(es) (provided within the

Transport Testing Tool) have been registered within the EHR technology and are

visible Direct addresses for transmitting of health information to the Transport

Testing Tool according to the ONC Applicability Statement for Secure Health

Transport (Direct) standard with XDM Validation

IN170.314.b.2 – 3.02: Using the Transport Testing Tool, the Tester shall verify that the transmitted C-CDA

document has been transmitted and received successfully according to the ONC

Applicability Statement for Secure Health Transport (Direct) standard with XDM

Validation, including successful decryption validation and trust anchor validation

IN170.314.b.2 – 3.03: Using the provided test data, and the Validation Report produced by the Transport

Testing Tool identified in the Conformance Test Tools section of this test

procedure, the Tester shall verify that

The C-CDA Implementation Guide conformance requirements tested are met

by the electronically generated (Ambulatory/Inpatient) Transition of

Care/Referral Summary

The standards for the named vocabularies for the Common MU Data Set,

Encounter diagnoses, and Immunizations are met by the electronically

generated Transition of Care/Referral Summary

IN170.314.b.2 – 3.04: The Tester shall identify the C-CDA .xml files within the transmitted documents

(This may involve parsing files and inspecting the header to identify the C-CDA

documents (vs. style sheet, human readable document, etc.))





2) Immunizations

3) Cognitive status




7) Provider name




1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity


7) Smoking status

8) Problems


16

9) Medications






15) Procedures






2) Immunizations

3) Cognitive status





1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity


7) Smoking status

8) Problems

9) Medications






15) Procedures



17

DTR170.314.b.2–4: Transmit Health Information Using SOAP Protocols (Optional)

Figure 2


VE170.314.b.2 – 4.01: The Vendor shall identify the SOAP endpoint for XDR and register the EHR

technology’s SOAP endpoint in the Transport Testing Tool

VE170.314.b.2 – 4.02: The Vendor shall identify a Contact Email address to be used for receipt of the

validation report generated by the Transport Testing Tool


TE170.314.b.2 – 4.01: The Tester shall cause the EHR to transmit Consolidated CDA document(s) for

Referral Summary/Transition of Care created in TE170.315.b.2 – 1.02 using

SOAP Protocols with XDR Validation to the SOAP endpoint available in the

Transport Testing Tool




accurate


IN170.314.b.2 – 4.01: Using the Transport Testing Tool, the Tester shall verify that the transmitted human

readable document(s) and C-CDA document(s) have been transmitted and

received successfully according to SOAP Protocols with XDR Validation


18





2) Immunizations

3) Cognitive status




7) Provider name




1) Patient name

2) Sex

3) Date of birth

4) Race

5) Ethnicity


7) Smoking status

8) Problems

9) Medications






15) Procedures






2) Immunizations

3) Cognitive status





1) Patient name

2) Sex

3) Date of birth

4) Race


19

5) Ethnicity


7) Smoking status

8) Problems

9) Medications






15) Procedures


TEST DATA

Test data is provided with the test procedure to ensure that the functional and interoperable requirements

identified in the criteria can be adequately evaluated for conformance, as well as, to provide consistency

in the testing process across multiple National Voluntary Laboratory Accreditation Program-Accredited

Testing Laboratories (ATLs). The provided test data focus on evaluating the basic capabilities of required

EHR technology, rather than exercising the full breadth/depth of capability that installed EHR technology

might be expected to support. The test data is formatted for readability of use within the testing process.

The format is not prescribing a particular end-user view or rendering. No additional requirements should

be drawn from the format.

The Tester shall use and apply the provided test data during the test, without exception, unless one of the

following conditions exists:

The Tester determines that the Vendor-selected message format requires some modification to

the test data.

The Tester determines that the Vendor product is sufficiently specialized that the provided test

data needs to be modified in order to conduct an adequate test. Having made the determination

that some modification to the provided test data is necessary, the Tester shall record the

modifications made as part of the test documentation.

The Tester determines that changes to the test data will improve the efficiency of the testing

process; primarily through using consistent demographic data throughout the testing workflow.

The Tester shall ensure that the functional and interoperable requirements identified in the

criterion can be adequately evaluated for conformance and that the test data provides a

comparable level of robustness.

Any departure from the provided test data shall strictly focus on meeting the basic capabilities

required of EHR technology relative to the certification criterion rather than exercising the full

breadth/depth of capability that installed EHR technology might be expected to support.

The test procedures require that the Tester enter the test data into the EHR technology being

evaluated for conformance. The intent is that the Tester fully controls the process of entering the

test data in order to ensure that the data are correctly entered as specified in the test procedure.

If a situation arises where it is impractical for a Tester to directly enter the test data, the Tester, at


20

the Tester’s discretion, may instruct the Vendor to enter the test data, so long as the Tester

remains in full control of the testing process, directly observes the test data being entered by the

Vendor, and validates that the test data are entered correctly as specified in the test procedure.

CONFORMANCE TEST TOOLS

The following testing tools are available to evaluate conformance to the standards referenced in this test

procedure:

Direct Certificate Discovery Tool (DCDT) – ONC provides a web application certificate discovery

testing tool to support this test procedure. This tool was created to support automated testing of

systems that plan to enact the Certificate Discovery and Provider Directory Implementation

Guide, approved as normative specification by the Direct community, as of July 9, 2012. It is

based on the written test package and requirement traceability matrix created by the Modular

Specifications project under the direction of the Office of the National Coordinator (ONC) and

National Institute of Standards and Technology (NIST).

This application can be installed and deployed locally.

The Direct Certificate Discovery Tool, User’s Guide, configuration instructions, and other

documentation are available at: http://code.google.com/p/direct-certificate-discovery-tool/

Support for this tool is available by contacting:

Avinash Shanbhag ([email protected])

Director, Nationwide Health Information Network Division

Office of Standards and Interoperability

Office of the National Coordinator for Health IT, HHS

Transport Testing Tool (TTT) – NIST provides a web application Transport Testing Tool designed

to support this test procedure. This test will not involve transport testing, however The Transport

Testing Tool includes the capability to verify Consolidated CDA documents. This component of

the Transport Testing Tool relies on Model Driven Health Tools (MDHT) for Consolidated CDA

validation developed by ONC.

The application can be downloaded for local installation

NIST is making available the web-site for pre-testing

The Transport Testing Tool is available at: http://hit-testing.nist.gov:9100/ttt

Documentation for the MDHT project used for C-CDA validation is available at:

https://www.projects.openhealthtools.org/sf/projects/mdht/

Support for this tool is available through the ONC-NIST co-managed Transport Testing Tool Google

Group. Access to the Transport Testing Tool Google Group is available at:

https://groups.google.com/d/forum/transport-testing-tool

Transport Testing Tool Contact:

Kevin Brady ([email protected])

Leader, Systems Interoperability Group

http://code.google.com/p/direct-certificate-discovery-tool/


http://hit-testing.nist.gov:9100/ttt

https://www.projects.openhealthtools.org/sf/projects/mdht/

https://groups.google.com/d/forum/transport-testing-tool



21

Acting Leader, Cyber Infrastructure Group

National Institute of Standards and Technology (NIST)

Information Technology Laboratory

The following information is provided to assist the Tester in interpreting the conformance reports

generated by the NIST conformance testing tools:

The NIST Transport Testing Tool, via MDHT, evaluates individual conformance statements which have

been derived from the standards and the "HL7 Implementation Guide for CDA® Release 2: IHE Health

Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012" identified in

the Final Rule and the test data provided in this test procedure. The validation tools evaluate the

submitted HL7 message instance for each conformance statement, and then produce a conformance

report. The Tester should consider that a report containing only Affirmative and Warning messages

indicates general conformance to the standard and test data expectations. If reported, errors should be

considered as significant departures from the standard or test data requirements which need to be

corrected in order to claim conformance. ATLs will need to further analyze each error to determine if, in

the context of meeting the criterion and overall meaningful use objective, the error results in a failure of

the test procedure by the EHR technology. The Tester may need to inspection test data values derived

from required vocabularies and code sets.


22

Document History

Version Number Description Date Published

1.0 Released for public comment October 17, 2012

2014 Test Procedure Draft for 170.314(b)(2 -

Documents

Transcript of 2014 Test Procedure Draft for 170.314(b)(2 -